Skip to main content
OpenTrials
Completed

NCT Number: NCT04914728

Mini-invasive Lumbar Arthrodesis in Ambulatory

Degenerative lumbar pathologies are characterised by functional impairment and the occurrence of severe chronic pain and disability Arthrodesis of the lumbar spine is a common surgery for the treatment of degenerative lumbar pathologies. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The development of mini-invasive techniques and the development of the Improved Rehabilitation after Surgery programmes, has considerably reduced the hospital stay of the patients. It is possible that in the future mini-invasive lumbar arthrodesis will be performed on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Unité de Chirurgie de la Colonne Vertébrale

Bruges, 33520, France

About this study

Degenerative lumbar disease (DLD) is a condition of increasing frequency, affecting millions of patients worldwide. They are characterised by functional impairment and the occurrence of severe chronic pain and disability.

Arthrodesis of the lumbar spine is a common surgery for the treatment of DLD. It is commonly performed during a hospital stay that can vary from 3 to 7 days. The advent of mini-invasive techniques and the development of Improved Rehabilitation after Surgery program has made it possible to considerably reduce the duration of hospitalization of patients with a high rate of satisfaction, a reduction in costs and without increasing morbidity. In spinal surgery, decompression procedures such as discectomy and lumbar recalibration are frequently performed on an ambulatory. The first American studies with a low level of evidence on the management of mini-invasive lumbar arthrodesis are beginning to appear. It is quite possible that in the future this type of procedure will be carried out on an ambulatory as a standard procedure, but its safety, efficacy and patient satisfaction must be proven and validated. In the United States, 23-hour hospitalizations are considered as ambulatory procedures, whereas in France, ambulatory is qualified as such when the patient is admitted and discharged in the same day.

The study population was patients who had failed medical treatment (analgesics and rehabilitation) for more than three months and who required a mono-segmental arthrodesis procedure for the management of their lumbar-radiculalgia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 75 years
  • Patients affiliated to a social security system.
  • Informed, dated and signed consent
  • ASA 1 or 2
  • Patient compliant and adhering to protocol visits
  • Indication for a 1-level mini-invasive lumbar arthrodesis performed by anterior or posterior approach
  • Failure of conservative treatment for more than 3 months

Exclusion criteria

  • History of lumbar arthrodesis
  • Active neoplasia
  • History of osteoporotic fractures of the spine
  • Arthrodesis superior to 1 level
  • Intolerance or contraindication to morphine treatments
  • Respiratory insufficiency
  • Preoperative anticoagulant treatment
  • Contraindication to the ambulatory care: patient living alone at home, or at a distance from the establishment, and thus requiring a follow-up care and rehabilitation hospitalization
  • Patient with a body mass index of greater than 40 kg/m².
  • Patient with a fever (>38°C)
  • Suspected or known allergy or intolerance to the materials used and requiring a combination of different metals.
  • Patient with a contraindication to the material used or for whom the use of the implant could interfere with their anatomical structures or expected physiological function.
  • Pregnant or breastfeeding women
  • Patient participating to an ongoing study that may interfere with the present study
  • Patient under legal protection

Treatment and study plan

mini-invasive lumbar arthrodesis

Procedure
  • The mini-invasive posterior approach is performed using a trans-muscular Wiltse approach. Pedicle screws, neurological decompression and intersomatic cage placement are performed.
  • The mini-invasive anterior approach is performed via a left retroperitoneal pararectal approach. After complete discectomy, an intersomatic cage stabilised by a screwed plate will be placed.

Primary outcomes

  1. To evaluate the feasibility of mini-invasive lumbar arthrodesis on an ambulatory in patients with degenerative lumbar disease who have failed with conventional treatment.

    Time frame: within 24 hours after surgery

    Percentage of patients with same-day discharge

Secondary outcomes

  1. Evaluate the safety of ambulatory lumbar arthrodesis

    Time frame: through study completion, an average of 1 year

    Record of adverse event

  2. Evaluate early morbidity

    Time frame: within 1st week

    Occurrence of re-hospitalization and/or emergency readmission and/or need for re-operation of the patient

  3. Evaluate the short-term morbidity

    Time frame: within 1st month

    Presence of a cicatrization disorder, the occurrence of an infection, neurological damage, adverse event related to the implants, vascular and/or medical problem.

  4. Evaluate the mid-term morbidity

    Time frame: within 1st year

    occurrence of pseudoarthrosis

  5. Evaluate the patients' quality of life

    Time frame: at 1-month visit

    Short Form-36 Health Survey questionnaire

  6. Evaluate the patients' quality of life

    Time frame: at 1-month visit

    Evaluated by Oswestry

  7. Evaluate the patients' quality of life

    Time frame: at 6-month visit

    Evaluated by Short Form-36 Health Survey questionnaire

  8. Evaluate the patients' quality of life

    Time frame: at 6-month visit

    Evaluated by Oswestry

  9. Evaluate the patients' quality of life

    Time frame: at 1-year visit

    Evaluated by Short Form-36 Health Survey questionnaire

  10. Evaluate the patients' quality of life

    Time frame: at 1-year visit

    Evaluated by Oswestry

  11. Evaluate the patients' quality of life

    Time frame: at 1-month visit

    Return to professional activity

  12. Evaluate the patients' quality of life

    Time frame: at 6-month visit

    Return to professional activity

  13. Evaluate the patients' quality of life

    Time frame: at 1-year visit

    Return to professional activity

  14. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: L1S1 lumbar lordosis

  15. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: Segmental lordosis of the arthrodesis level

  16. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: Pelvic Incidence

  17. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: Pelvic version

  18. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: Sacral slope

  19. Evaluate radiological parameters

    Time frame: at 1-month visit

    The radiological parameter: Disc height

  20. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: L1S1 lumbar lordosis

  21. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: Segmental lordosis of the arthrodesis level

  22. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: Pelvic Incidence

  23. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: Pelvic version

  24. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: Sacral slope

  25. Evaluate radiological parameters

    Time frame: at 6-month visit

    The radiological parameter: Disc height

  26. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: L1S1 lumbar lordosis

  27. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: Segmental lordosis of the arthrodesis level

  28. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: Pelvic Incidence

  29. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: Pelvic version

  30. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: Sacral slope

  31. Evaluate radiological parameters

    Time frame: at 1-year visit

    The radiological parameter: Disc height

  32. Evaluate patient satisfaction with the procedure

    Time frame: at 1-month visit

    Satisfaction score

  33. Evaluate patient satisfaction with the procedure

    Time frame: at 6-month visit

    Satisfaction score

  34. Evaluate patient satisfaction with the procedure

    Time frame: at 1-year visit

    Satisfaction score

  35. Evaluate lumbar pain

    Time frame: at 1-month visit

    Lumbar Visual Analogue Scales pain

  36. Evaluate lumbar pain

    Time frame: at 6-month visit

    Lumbar Visual Analogue Scales pain

  37. Evaluate lumbar pain

    Time frame: at 1-year visit

    Lumbar Visual Analogue Scales pain

  38. Evaluate radicular pain

    Time frame: at 1-month visit

    Radicular Visual Analogue Scales pain

  39. Evaluate radicular pain

    Time frame: at 6-month visit

    Radicular Visual Analogue Scales pain

  40. Evaluate radicular pain

    Time frame: at 1-year visit

    Radicular Visual Analogue Scales pain

  41. Evaluate lumbar and radicular pain

    Time frame: before the 1-month visit

    record of analgesic treatments taken before and after surgery

Sponsors and collaborators

Lead sponsor

Elsan

Other

Registry information

Official study title

Mini-invasive Lumbar Arthrodesis in Ambulatory: Pilot Study "ALAMBU"

Acronym: ALAMBU

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 7, 2021
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.